{"data":{"id":"us/21-cfr-814.15","jurisdiction":"us","citation":"21 CFR 814.15","heading":"Research conducted outside the United States.","body":"(a) Data to support PMA. If data from clinical investigations conducted outside the United States are submitted to support a PMA, the applicant shall comply with the provisions in § 812.28 of this chapter, as applicable.\n(b) As sole basis for marketing approval. A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if:\n(1) The foreign data are applicable to the U.S. population and U.S. medical practice;\n(2) The studies have been performed by clinical investigators of recognized competence; and\n(3) The data may be considered valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on-site inspection or other appropriate means.\n(c) Consultation between FDA and applicants. Applicants are encouraged to meet with FDA officials in a “presubmission” meeting when approval based solely on foreign data will be sought.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES","Subpart A—General"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"1c23cba941ce332df27825521198ef8544dbfe70135e46555eb22bfc0e69af5e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-814.9","next":"us/21-cfr-814.17"},"notice":"GroundRules: Original legal text. Not legal advice."}